The high drug prices she decries are not the result of market forces gone wild, but rather bad regulation.

By SCOTT GOTTLIEB

Sept. 29, 2015 7:18 p.m. ET

103 COMMENTS

Hillary Clinton’s prescription to soothe the economic hangover consumers have from ObamaCare’s regulatory binge is a single ingredient: more regulation. Mrs. Clinton begins her treatment plan by focusing on “price gouging” by pharmaceutical companies and the need for price regulation.

Major biotech indexes are down about 20% since Mrs. Clinton first tweeted news of her plan on Sept. 21. What she fails to comprehend is that the high drug prices she decries aren’t the result of market forces gone wild. Rather, they are the result of bad regulation that has created market failures and shortages.

Take Turing Pharmaceuticals, which has come under fire for raising the price of Daraprim, a drug used for decades to treat toxoplasmosis and more recently to treat AIDS and cancer patients, to $750 from $13.50 a tablet. In a Sept. 20 interview, Turing CEO Martin Shkreli said the increase was needed to stay in business and research new medicines. “This drug was doing $5 million in revenue,” he said, “and I don’t think you could find a drug company on this planet that could make money on $5 million of revenue.”

Mr. Shrkeli has since backed away from the $750 price, saying Turing will announce a new, lower price for Daraprim in the weeks to come. But Turing has been attempting to exploit a regulatory failure that is becoming far more prevalent as the Food and Drug Administration knocks older generic medicines out of production and barriers to entry make new generics costlier.

Turing bought marketing rights to Daraprim from another company, along with access to a supply of the drug, so it didn’t need to do any weighty regulatory work to market the medicine. It rebranded the pill and raised the price. But if another company wanted to compete to sell the same medicine, it would need to apply for a new generic drug approval, by submitting an “Abbreviated New Drug Application” to the FDA.

Filing one of these applications with the FDA used to cost as little as $1 million; today it can run as high as $20 million, sometimes more. This means that old but “niche” drugs may not have competition from other generic entrants, creating an opening for companies to extract windfall profits by driving up the prices of drugs like Daraprim.

The FDA has a backlog of thousands of generic-drug applications. And it takes an average of four resubmissions for a generic application to finally win approval, partly owing to shortcomings in the applications and poor communication between the FDA and generic drug makers. It may well be that competitors to Daraprim are in the FDA’s large queue. On average, it takes about 50 months for the FDA to approve a single generic application.

The FDA’s recent crackdown on the manufacturing process of prescription drugs has also led to the shutdown of U.S. drug plants. Whatever the merits of the FDA’s heightened scrutiny, it has been done with little attention to how this manufacturing capacity would be replaced. The slow approval timelines, combined with closed manufacturing facilities, create temporary drug shortages and monopolies, which can be exploited by shrewd investors.

It’s important to distinguish between new medicines that are priced at a premium because they represent genuine innovation and risk-taking, and drugs that are priced high simply because investors are manipulating regulatory failures. If Mrs. Clinton is serious about helping patients, she should focus on lowering the cost and time necessary for generic-drug entry, thus reducing the chance of perpetual monopolies for old, off-patent drugs like Daraprim.

Yet Mrs. Clinton’s proposed policy changes are mostly focused on new medicines that are transforming the treatment of disease, but also take a lot of risk and cost to develop. More than 40% of the drugs approved by the FDA in 2014 treat rare or vexing medical problems, including a cure for hepatitis C, the first and only vaccine for meningococcal B, and a radical treatment for metastatic melanoma—a disease that was once a death sentence. About 70% of the drugs in development are “first in class” medicines, meaning they use a completely new approach in fighting a disease.

In the age of genomics and molecularly targeted drugs, this often means aiming new medicines at smaller groups of patients. Drugs that target smaller groups are invariably priced higher, since the huge investment to discover and develop them, and earn the value they deliver, needs to be recouped by fewer prescriptions.

Blaming the high cost of drugs on a lack of price controls in ObamaCare fits the populist narrative in this election season. But high-cost specialty drugs constitute a fraction of health-care spending. Overall, the cost of drugs—at about 10% of total health-care spending—hasn’t budged in 50 years.

The real reason that Mrs. Clinton’s rhetorical stratagem will sell is that ObamaCare has left many consumers badly insured for “specialty” drug costs. It has done so by popularizing “closed” drug formularies that only cover a fraction of these new medicines, and leave consumers carrying the full cost of drugs not on the formulary lists. It has also promoted high deductibles, and the use of eye-popping copays.

As people experience ObamaCare’s hollowed-out insurance policies—and their costs—consumers want to know the reasons. The architects of the plan, including Mrs. Clinton, are doing their best to deflect that blame.

Dr. Gottlieb is a physician and resident fellow at the American Enterprise Institute. He consults with and invests in health-care services companies.

Raúl Modesto Castro Ruz was born on June 3, 1931, in Birán, a village in eastern Cuba. He was the sixth of nine children of Angel Castro Argiz, a landowner originally from Spain. Raúl’s mother was not Castro’s wife; she was a servant in the family’s home. Raúl’s brother Fidelis five years older. According to physical features and promiscuity of the mother all rumors indicate Raul’s father is somebody else, possibly a Chinese-Cuban captain, called Mirabal. Raul godfather was Fulgencio Batista who became a Cuban dictator during 7 years, who Raul admired and used to dress like Batista’s soldier When he was 12 yo. Raul was the center of scandal in Biran when he got involved with a 17 y.o. mulatto who raped him and who was found dead next day – data confirmed by neighbors.

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Raul and Mirabal

Raúl and Fidel were sent away to attend school in Santiago de Cuba, but the brothers were kicked out for bad behavior. They went on to a Jesuit-run school, the Belen Academy. While Fidel became a good student there, Raul did not. Fidel was not a very advanced student either, he entered high school at 14 y.o. (regularly 12 y.o) and ended been 19 years old (regularly 17 y.o.) The Jesuit teachers found out that both were bastards and Angel and Lina had to marry in order to accept Raul as a student at Belen School. After failing classes, he soon left school and returned to the family estate. According to Father Llorente, Raul was expelled because of his poor behavior and disobedience, which Fidel had to admit saying: ” Father I know my brother Raul is a good-for- nothing”. He later took some classes in administration at the University of Havana, ? but he never graduated. By reputation, he preferred drinking and gambling to studying.

Raúl became politically involved after attending a socialist youth meeting in Vienna in 1953. Fidel became a student activist while at the University of Havana. Not exactly he was a gangster who used to carry guns. The brothers soon began taking part in violent protests against the regime of Cuban dictator Fulgencio Batista. On July 26, 1953, they helped organize an attack on the military barracks at Moncada. Both Castros cowardly forced young boys into death, but they never participated in the Moncada assault.The Castros were captured and spent two years in prison. They were not captured, they presented to Batista’s police accompanied by a priest to avoid being killed . After their release, they went to Mexico, where they continued planning Batista’s overthrow. There, Raúl met Argentine revolutionary Che Guevara and introduced him to Fidel.

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Fulgencio Batista and Raul Castro el “Cabo Pulguita”

Raúl returned to Cuba with the other revolutionaries in 1956. Years of fighting culminated in Batista’s 1959 overthrow. Fidel Castro then took power, stating that if he was killed, “behind me come others more radical than me,” referring in part to his brother.

Raúl acted as an executioner during the revolution as well as after his brother took power. He was known for his ruthlessness and brutality. Years later, he suggested that his nickname should be “Raúl the Terrible” for his role in hundreds of killings.He had been called “China Roja” by the Sierra Maestra guerrillas, because of his feminity and his Asiatic resemblance. He even executed a close friend, Gen. Arnaldo Ochoa, on orders from Fidel in 1989.

Four months after the Cuban Revolution, Raúl married Vilma Espín Guillois, forced to cover rumors that he was a homosexual. Her background was very different from most of the rebel fighters: She was from a wealthy family, trained as an electrical engineer, and had studied at MIT. Vilma took on many of the ceremonial duties of the first lady of Cuba, since brother-in-law Fidel was divorced. She was also an official of the Cuban Communist Party and founder of the Federation for Cuban Women. Vilma and Raúl had four children and eight grandchildren. She died in June 2007 after a long illness.

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Vilma Espin First at left.

Raúl was his brother’s designated successor for 47 years. He headed the Cuban military during that time, becoming the longest-serving defense minister in the world. He was also vice president of the Council of State and second secretary of the Cuban Communist Party. In contrast to his brother, Raúl has generally preferred to work behind the scenes. In 1991, he joked with Cuban journalists that his relative obscurity had led to rumors of his death: “They were saying I was being kept in a freezer.”

Raúl Castro worked closely with the Soviet Union during the first decades of his career. Without Fidel’s knowledge, Raúl made Cuba’s first official contact with that nation in 1959. He also negotiated with the Soviets to place missiles on the island, which led to military conflict with the United States and the Bay of Pigs invasion in 1961.

Cuba relied heavily on the Soviet Union for financial support until that country broke up in 1991. Raúl managed Cuba’s transition away from Soviet assistance, administering military cutbacks and placing generals in charge of key government functions like transportation and tourism. He confessed he ordered to shoot down unarmed planes of Brothers to the Rescue which helped the boats people He was noted for his pragmatism, collaboration, and receptiveness to some economic reforms. Raúl is said to be an admirer of the Chinese economic model.

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In 2006, Raúl took over the day-to-day leadership of Cuba after Fidel had abdominal surgery. Some analysts have suggested that Raúl Castro might be more open to working with the United States government than his brother was. He reads speeches written by someone else and avoids answering using jokes and with poor responses.

RUSSIA CAUSES TENSION: Between US During Syrian Airstrikes [WATCH]

Looks like Putin/Obama feud is still alive and well.

Russian warplanes began bombarding Syrian opposition targets in the war-torn nation’s north Wednesday, following a terse meeting at which a Russian general asked Pentagon officials to clear out of Syrian air space and was rebuffed, Fox News has learned.

A U.S. official said Russian airstrikes targeted fighters in the vicinity of Homs, located roughly 60 miles east of a Russian naval facility in Tartus, and were carried out by a “couple” of Russian bombers. The strikes hit targets in Homs and Hama, but there is no presence of ISIS in those areas, a senior U.S. defense official said. These planes are hitting areas where Free Syrian Army and other anti-Assad groups are located, the official said.

According to a U.S. senior official, Presidents Obama and Putin agreed on a process to “deconflict” military operations. The Russians on Wednesday “bypassed that process,” the official said.

“That’s not how responsible nations do business,” the official said.

The development came after Pentagon officials, in a development first reported by Fox News, brushed aside an official request, or “demarche,” from Russia to clear air space over northern Syria, where Moscow said it intended to conduct airstrikes against ISIS on behalf of Assad, according to sources who spoke to Fox News. The request was made in a heated discussion between a Russian three-star general and U.S. officials at the American Embassy in Baghdad, sources said.

“If you have forces in the area we request they leave,” said the general, who used the word “please” in the contentious encounter.

A senior Pentagon official said the U.S., which also has been conducting airstrikes against ISIS, but does not support Assad, said the request was not honored.

“We still conducted our normal strike operations in Syria today,” the official said. “We did not and have not changed our operations.”

State Department spokesman John Kirby told reporters the Russian airstrikes won’t change the strategy of the U.S.-led coalition.

“The U.S.-led coalition will continue to fly missions over Iraq and Syria as planned and in support of our international mission to degrade and destroy ISIL,” Kirby told reporters, while acknowledging the meeting at the American embassy in Baghdad.

Russia’s Foreign Minister Sergey Lavrov told foreign ministers of world powers Wednesday that his country is “ready to forge standing channels of communication to ensure a maximally effective fight against terrorist groups.”

Lavrov spoke to the U.N. Security Council shortly after Russia’s defense ministry announced its jets are carrying out airstrikes on Islamic State group positions in Syria.

Lavrov said Russia would shortly circulate a draft council resolution to promote joint efforts against groups like the Islamic State.

The move by Moscow marks a major escalation in ongoing tensions between the two countries over military action in the war-torn country and comes moments after Russian lawmakers formally approved a request from Putin to authorize the use of troops in Syria. Putin said previously that Russia would strike ISIS targets.

Gentlemen lets put things in perspective regarding the Popes visit

Carlos Miyares

“Dear Mom and Dad,

I’ve just received the news that I’ll be executed by firing squad in the morning. I assure you, dear parents, that I’ve never felt such spiritual tranquility as I do now. I feel content knowing that very shortly I’ll be with God, waiting and praying for you, my parents. I realize this news is painful for you, but please have faith in the Eternal Life. I want you all to rise above this and know that God, in his infinite mercy, has given me the grace to reconcile with Him… Hugs and kisses, not tears, for everyone. Goodbye, my dear family. Have faith in God.

A deafening blast and Soviet bullets ripped apart the head and torso of yet another young Cuban martyr. Albert Tapia was barely 21 years old, typical age for most of Castro and Che’s murder victims.

“The defiant yells (“Viva Cristo Rey!”—“Viva Cuba Libre!”-“Abajo Comunismo!”)from the bound and staked martyrs “would make the walls of La Cabana prison tremble!” wrote eyewitness to the slaughter, Armando Valladares, who suffered 22 torture-filled years in Castro’s prisons and was later appointed by Ronald Reagan as U.S. ambassador to U.N Human Rights Commission.

Given their valiant defiance even during their last seconds alive, by mid 1961 the mere binding and blindfolding of Castro and Che’s young murder victims wasn’t enough. The fine folks who hosted Pope Francis’ in Cuba this week then began ordering that the Catholic youths also be gagged. The shaken firing-squads demanded it. The yells were badly unnerving the trigger-pullers, you see.

So now, as the fine folks who hosted Pope Francis’ in Cuba this week yanked the young Catholic heroes from the cells, bent their arms back, and bound their hands, two more Communist guards came into play. One grabbed the struggling victim’s hair and jerked his head back, trying to steady him. The other taped his mouth shut.

Raul Castro (who hosted the Pope at last week’s Havana Mass) and Che Guevara (whose visage formed the backdrop for the Mass) were the most notorious executioners during the early years of the Cuban Revolution. The orders, of course, all issued from Fidel Castro, who Pope Francis went out of his way to visit and smilingly hob-nob with after the Mass, profusely thanking him for his efforts towards “world peace,” (I am NOT making this up!)

“I am not Christ or a philanthropist,” wrote Che Guevara in a letter to his mother. “I am all the contrary of a Christ–In fact, if Christ himself stood in my way, I, like Nietzsche, would not hesitate to squish him like a worm.”

As mentioned: an enormous image of Che Guevara formed the backdrop to Pope Francis’ Mass in Havana last week.

Castro’s KGB and STASI- tutored regime prepared for the Pope’s visit carefully. Any unsightly protests would obviously mar the occasion, especially for a regime long-accustomed to preening in front of the international media mirror. So Cuban dissidents (especially Catholic ones) were rounded up en-masse by Castro’s KGB-trained police, often brutally.

“The facts and figures are irrefutable. No one will any longer be able to claim ignorance or uncertainty about the criminal nature of Communism,” wrote the New York Times (no less!) about The Black Book of Communism. This “irrefutable” study on Communism’s crimes was edited by the head of France’s National Centre for Scientific Research, Stephane Courtois (not exactly an embittered dispossessed Cuban exile) and translated into English by Harvard University Press (not exactly a subsidiary of the John Birch Society.)

This impeccably high-brow scholarly study found that Castro and Guevara’s firing squads murdered between 15 and 17 thousand Cubans, the equivalent, given the U.S. population, of almost one million executions. Some more perspective: the UN, (the same United Nations that proudly features Cuba on its Human Rights Council, by the way) charged former Serbian dictator Slodoban Milosevic with “genocide” for ordering 8000 executions.

And far from any of the repentance the Catholic Church supposedly requires for forgiveness, the Castro brothers have always doubled–and even tripled-down–on their gloating for those thousands of murders, historically denouncing the young victims as “CIA mercenaries!” and “terrorists!”

None of this has prevented the Castro regime from receiving the most papal visits recently of any Latin America nation, equaling the number of papal visits to Brazil, with a population of 200 million, 130 million of them declared Catholics. In contrast, Cuba has a population of 11 million, only a tiny fraction of which are practicing Catholics. Someone’s got some serious “‘splainin” to do for this Papal fetish of constantly visiting Stalinist Cuba and chumming around with her Stalinist rulers.

Interestingly, more Popes (three) have recently visited Cuba–a nation with many more crypto-voodooists (Santeros) than Catholics– than have visited Mexico(with 97 million Catholics.) Hello? Andas Joan Rivers used to ask: “Can we talk?” (about this glaring and –for many—disgusting incongruity.)

For many of us, the Papal motivation for visiting Cuba seems no different from Beyonce’s, Conan O’Brien’s, Jack Nicholson’s, Oliver Stone’s, Sean Penn’s, etc. The Popes get plenty of press and get to poke Uncle Sam in the eye. In this respect, they seem no different from all those loud-mouthed, Castro-hugging celebrity popinjays.

Obama calls on US to resettle ‘at least 10,000’ Syrian refugees in 2016 fiscal year

New target not enough to clear backlog of 15,200 refugees awaiting resettlement as aid groups criticize move for being ‘barely a token contribution’

Refugees and migrants wait for the bus to transport them onward after their arrival from the north-eastern Greek island of Lesbos to the Athens port of Piraeus. Photograph: Thanassis Stavrakis/AP

The White House announced on Thursday that President Barack Obama had called for resettling “at least 10,000” Syrian refugees in the United States in the next fiscal year, in what would be an exponential acceleration of US efforts so far to welcome the refugees.

But the plan immediately met with criticism from across the political spectrum, including an influential member of Congress who warned of security risks and aid groups who said the plan did not go far enough to address a historic humanitarian crisis.

While the 10,000 figure represented a significant leap above the 1,800 Syrian refugees total that the United States was expected to have admitted by the end of this month, it would not be enough to clear a backlog in the US resettlement program.

Under a referral program managed by the United Nations, 15,200 Syrian refugees currently await processing by the United States for resettlement, according to State Department figures. Security vetting and other processing for each refugee normally takes 18 to 24 months post-referral, the State Department has said, but aid groups have put the typical wait time at closer to about 33 months.

Challenged at a news conference on Thursday to explain whether the United States planned to accelerate its vetting process to admit 10,000 refugees in the next year, a State Department spokesman, John Kirby, said “there’s a significant national security concern that must be met”.

“I’m not arguing that we’re going to cut corners here,” Kirby said. “But the president has laid out his decision and the target he wants to achieve for the next fiscal year with respect to Syrian refugees, and we’re going to work very hard to do that.”

Congressman Michael McCaul, a Republican from Texas and chairman of the House homeland security committee, said the new White House plan was “the culmination of a failed foreign policy”.

“The president wants to surge thousands of Syrian refugees into the United States, in spite of consistent intelligence community and federal law enforcement warnings that we do not have the intelligence needed to vet individuals from the conflict zone,” McCaul said in a statement. “We also know that Isis [Islamic State] wants to use refugees routes as cover to sneak operatives into the west. I implore the president to consult with Congress before taking any drastic action and to level with the American people about the very real security challenges we face.”

Refugee advocacy groups, on the other hand, said the administration had beentoo slow to respond to the Syrian refugee crisis. Human Rights First, a non-partisan advocacy organization, called on the president to commit to resettle at least 100,000 Syrian refugees during the next fiscal year.

“This is not leadership, it is barely a token contribution given the size and scale of the global emergency,” said Human Rights First’s Eleanor Acer in a statement. “The administration’s announcement that it will commit to take in at least 10,000 Syrian refugees is far too little. Resettling 10,000 Syrian refugees is only a drop in the bucket toward providing protection to the more than 4 million Syrians who have fled their country due to horrific violence and persecution.”

The United States resettled 1,293 refugees from Syria between October 2014 and the end of August, according to State Department figures. The state accepting the most refugees from Syria in that time period was Texas, with 150. Michigan accepted 139, California accepted 128 and Illinois accepted 111.

The Syrian conflict is estimated to have displaced at least 11.6 million people.

Outside of Syria, the brunt of the Syrian refugee crisis has been felt by immediate neighbors, including Jordan, Turkey and Lebanon, which at one point in 2014 was estimated to have accepted 20,000 refugees a day.

Germany has committed to accepting 800,000 refugees over the next 10 years, while the British prime minister, David Cameron, has said the UK will accept 10,000.

Kirby said that in addition to its commitment to resettling refugees, the United States had spent $4bn on security and fresh water and food for Syrian refugees living in camps.

“No other country is more generous than the United States in this regard,” Kirby said.

“I take issue with this idea that our contributions are paltry or insignificant in any way. That’s not borne out by the facts. It’s at least 10,000 and it could go up.”

The White House proposal followed a visit by the secretary of state, John Kerry, to Capitol Hill on Wednesday in which he reportedly urged Congress to lift the number of refugees the United States accepts annually from around the world above the 70,000 who arrived in the 2015 fiscal year. The two sides had discussed 5,000 additional refugees a year, according to congressional and administration sources cited by the Associated Press.

The House minority leader, Nancy Pelosi, said on Thursday that the 5,000 figure “is far too low”, pointing out that the United States accepted more than 200,000 refugees annually after the Vietnam war.